Text Size

Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

This study is not yet open for participant recruitment.
Verified June 2011 by Rambam Health Care Campus
Sponsor:
Collaborator:
Merck KGaA
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01382407
First received: June 23, 2011
Last updated: June 24, 2011
Last verified: June 2011
History of Changes
  Purpose

The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.


Condition Intervention
Colorectal Cancer Metastatic
 Drug: Cetuximab

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?

Resource links provided by NLM:

Drug Information available for: Cetuximab
U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: June 2013
Groups/Cohorts Assigned Interventions
Cetuximab
All patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy.
 Drug: Cetuximab
Once a week:Loading dose-400 mg/m2;subsequent-250 mg/m2 on days 8,15, 22,29,36 if administered as a single agent, or together with Irinotecan 125 mg/m2 on days 1,8,15,29 followed by administration every 42 days.
Other Name: Erbitux

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients above the age of 18 years, who have been diagnosed with confirmed KRAS-WT mCRC, and are starting treatment with cetuximab, will be informed of the study.

Criteria

Inclusion Criteria:

  • Age above 18 years.
  • Histology or cytology proven KRAS-WT mCRC.
  • Performance status ≤3 (Eastern Cooperative Oncology Group [ECOG] classification)
  • Life expectancy of more than 12 weeks.
  • Written informed consent.
  • In women of childbearing potential, appropriate contraceptive measures must be used during treatment with cetuximab and for 6 months following the last dose of cetuximab.

Exclusion Criteria:

  • Past systemic immune therapy for disease other than cancer.
  • Past immune or other target therapy for cancer (not including bevacizumab).
  • Presence of acne or acneiform rash prior to starting treatment with cetuximab.
  • Patients with treatment plan of cetuximab and capecitabine combination.
  • For female patients: the patient is pregnant or lactating.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382407

Contacts
Contact: Gil Bar-Sela, M.D. +972-4-8543810 g_barsela@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Not yet recruiting
Haifa, Israel, 31096
Contact: Gil Bar-Sela, M.D.     +972-4-8543810     g_barsela@rambam.health.gov.il    
Principal Investigator: Gil Bar-Sela, M.D.            
Sponsors and Collaborators
Rambam Health Care Campus
Merck KGaA
Investigators
Principal Investigator: Gil Bar-Sela, M.D. Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Gil Bar-Sela , MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01382407     History of Changes
Other Study ID Numbers: B427CTIL
Study First Received: June 23, 2011
Last Updated: June 24, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
skin rash reaction
ERBITUX® (cetuximab)
acne

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013